Analista de assuntos regulatórios [farma] – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Farmacêutico
Químico

Responsabilidades

• Prepare and submit regulatory submissions with support from regulatory operations;
• Reply HA queries timely;
• Work on different project within RA
• Participate in internal working groups as required and address any regulatory actions with senior RA colleagues;
• Preparation/update and submission of packaging components for registered products. Artwork review/approval prior implementation;
• Group discussion participation and regulations study;
• Participation in products launch team;
• Keep tracking on Regulatory submissions/approvals;
• Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems);
• Maintain an awareness of regulatory guidelines/directives/national requirements;
• Send spontaneous queries to the appropriate person;
• Keep tracking on Regulatory submission/approvals in regulatory systems;
• Contributes in the development and implementation on local SOPs;
• Training on global, regional and local SOP.

Requisitos

• Superior Completo em Farmácia, Biologia, Bioquímica, Microbiologia, Química ou áreas afins;
• 2 anos de experiência na área regulatória;
• Experiência em legislações da Indústria Farmacêutica;
• Pacote office;
• Conhecimento das Boas Práticas de Documentação e Fabricação;
• Habilidade de resolução de problemas;
• Inglês avançado (espanhol desejável).